The Recall Desk

Manufacturer

X Spine Systems Inc

7 recalls in our database name X Spine Systems Inc as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
2
Most recent
2016-10-26

Of the 7 recalls from X Spine Systems Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (29%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • SevereFDA (Devices)·Z-0127-2017·2016-10-26

    X Spine Systems Recalls Calix T PEEK Lumbar System Trial Devices

    X Spine Systems is recalling 1,186 Calix T PEEK Lumbar System trial devices because components may detach and lodge in the intervertebral space during surgery.

    Product
    Calix T PEEK Lumbar System, TLIF Trial
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0126-2017·2016-10-26

    X Spine Systems Recalls Calix T PEEK Lumbar System TLIF Rasps

    X Spine Systems is recalling 195 units of Calix T PEEK Lumbar System TLIF Rasps because the tools may detach and become lodged in the surgical site.

    Product
    Calix T PEEK Lumbar System, TLIF Rasp
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0124-2017·2016-10-26

    X Spine Systems Recalls Calix P PEEK Lumbar System PLIF Rasps

    X Spine Systems Inc is recalling 182 units of Calix P PEEK Lumbar System PLIF Rasps because the tools may detach and become lodged in the surgical site.

    Product
    Calix P PEEK Lumbar System, PLIF Rasp
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0125-2017·2016-10-26

    X Spine Systems Recalls Calix P PEEK Lumbar System Trial Devices

    X Spine Systems is recalling 1,504 Calix P PEEK Lumbar System trial devices because parts may detach and lodge in the surgical site.

    Product
    Calix P PEEK Lumbar System, PLIF Trial
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1823-2015·2015-07-01

    X Spine Systems Recalls Fortex Pedicle Screw System Rods

    X Spine Systems is recalling 75 Fortex Pedicle Screw System Continuous Radius Rods because they measure 45mm instead of the specified 50mm.

    Product
    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1512-2015·2015-04-29

    Xpress System Pedicle Screw Assembly Recalled for Incorrect Laser Marking

    X Spine Systems Inc is recalling 14 units of Xpress System Pedicle Screw Assemblies because the laser marking on the yoke incorrectly states 7.5 x 55mm instead of 5.5 x 55mm.

    Product
    Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2136-2014·2014-08-13

    X Spine Systems Recalls Serrated Soft Tissue Shields for Spinal Surgery

    X Spine Systems Inc is recalling Serrated Soft Tissue Shields from the Silex Sacroiliac Fusion System because Revision B is 7 mm longer than the previous design.

    Product
    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
    Category
    Medical Device
    Distribution
    2 states